Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND) (NCT04579120) | Clinical Trial Compass
RecruitingNot Applicable
Neuroimaging in Healthy Aging and Senile Dementia (HASD_IND)
United States650 participantsStarted 2021-09-01
Plain-language summary
To identify factors that signal the transition from asymptomatic (preclinical) to symptomatic Alzheimer disease (AD).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, any race
* Age \> 18 years
* Participation in one of the ongoing projects affiliated with the Knight ADRC at Washington University and referred by the MAP staff and a Washington University physician.
* Normal cognition or early-stage symptomatic AD
* Willing and able to undergo study procedures.
* Capacity to give informed consent and follow study procedures
Exclusion Criteria:
* Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still during the scanning procedures);
* Has hypersensitivity to either AV-1451 or PIB or any of its excipients;
* Contraindications to PET, CT or MRI (e.g. electronic medical devices, inability to lie still for extended periods) that make it unsafe for the individual to participate;
* Severe claustrophobia;
* Currently pregnant or breast-feeding. Women must agree to avoid becoming pregnant and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Flortaucipir injection;
* Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
* Must not participate in another drug or device study prior to the end of this study participation;
* Cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AD Biomarkers seen on Amyloid PET at Baseline and Years 1, 2, and/or 3
Timeframe: 5 years
2
AD Biomarkers seen on Tau PET at Baseline and Years 1, 2, and/or 3
Timeframe: 5 years
3
AD Biomarkers seen on MRI at Baseline and Years 1, 2, and/or 3
Timeframe: 5 years
4
Compare and Correlate Predictive Ability of Biomarkers Seen with Different Imaging Variables for Onset of Symptoms